MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO LARGE APPLIER; APPLIER, HEMOSTATIC CLIP

Catalog Number	EL414
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a gastrostomy, the angle of opening and closing of the jaws is too large.The clip will automatically release and slip when it is clamped.There was delay of surgery.The surgery was completed successfully.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the el414 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming.The event described could not be confirmed as the device performed without any difficulties noted.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .

• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8321300
• Report Number: 3005075853-2019-16485
• Device Sequence Number: 13468863
• Product Code: HBT
• UDI-Device Identifier: 10705036003861
• UDI-Public: 10705036003861
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EL414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/18/2019
• Patient Sequence Number: 1